fMRI scan study to find out how nalmefene works (ver 1)

• Research type

  Research Study

• Full title

  Interventional, randomized, double-blind, cross-over, placebo-controlled study to investigate the effects of nalmefene after single dose on the blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding in the monetary incentive delay task (MIDT), in non-treatment seeking subjects with alcohol dependence following alcohol challenge (13-506)

• IRAS ID

  136514

• Contact name

  Frans van den Berg

• Contact email

  rec@hmrlondon.com

• Sponsor organisation

  H Lundbeck A/S

• Eudract number

  2013-001154-98

• ISRCTN Number

  n/a

• Research summary

  Nalmefene (Selincro®) is a medicine that’s recently been licensed in Europe to reduce alcohol intake in people with an alcohol problem.

  We’d like to learn more about how nalmefene works. It might reduce the feeling of reward that drinkers get when they drink; or make them less likely to act on impulse; or make them feel less stressed and so less in need of a drink. We’re doing this study to find out more about where nalmefene acts in the brain and its effects on brain activity.

  We’ll study 22 men, aged 20–65 years, who drink heavily but who are not seeking treatment for their drinking. We’ll use functional magnetic resonance imaging (fMRI) – a scan that uses magnetism to take pictures of the brain.

  Participants will have 2 study sessions. They’ll take nalmefene in 1 session and placebo in the other. First, we’ll give them alcohol by slow injection into a vein. If they tolerate that, they’ll have 2 fMRI scans – one in each session. During scans, they’ll:
  * receive alcohol (by slow injection into a vein)
  * do a computerised task – they’ll respond to a screen by pressing a button
  * look at images designed to bring out a range of emotions, some of which may be upsetting

  Participants will take up to 6 weeks to finish the study. They’ll stay on the ward for 5 nights in total, and make 2 outpatient visits. Participants can’t drink alcohol on the ward.

  A pharmaceutical company (H Lundbeck A/S) is funding the study.

  The study will take place at 2 research centres in London: Imanova will do the fMRI scans, and Hammersmith Medicines Research will do the other study procedures. Some procedures will be done in collaboration with Imperial College.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  13/LO/1268

• Date of REC Opinion

  1 Oct 2013

• REC opinion

  Further Information Favourable Opinion